Total Quality Management (TQM): Definition, elements, philosophies Bachelor of Pharmacy Subject Code: BP706TT SEMESTER: VII Subject Name: Quality Assurance JAFARALI MASI

1. TOTAL QUALITY MANAGEMENT
QUALITY ASSURANCE
B.PHARMA SEMESTER 7
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Introduction
The pharmaceutical industry is key part of the health care system.
The regulation of this industry is very important because one mistake in production or
design can cause more severe condition in relation to health care system. So, the
maintenance of the quality of the drugs is so important in pharmaceutical industries
because the poor quality of drugs can cause health hazards and economical burden for
both the government and patients.
Total quality management is improvised in the industries to maintain the quality and
safety of the drugs and prevention of the defects rather than the detection.
The pharmaceutical quality system is described under ICH guideline Q10. The
concepts, key points of quality improvement of TQM were proposed by several
eminents like Edward Deming, Joseph Juran, Philip Crosby, Genichi Taguchi, etc.
Definition
As per ISO, TQM is defined as: “A management approach of an organization centered
on quality, based on participation of all its members and aiming at long term benefits
to all members of the organization and society”.
Focus of TQM
There are three main key components of TQM:
1. Consumer/Customer focus
2. Involvement of employee
3. Continuous improvement

2. TQM is controlled by customer focus, process (planning, management and
improvement) and total participations. According to previous literature (Mazumder et
al, 2011), the key ingredients of TQM are:
1. Strategic commitment by the management
2. Employee involvement
3. Materials used in the organizations
4. Precise techniques used by the organizations and
5. Improved methods
Statistical Quality Control
To achieve accuracy, statistics play an important role in quality management systems.
The seven major tools used for statistical process control are:
1. Histogram: A histogram is an accurate representation of the distribution of
numerical data (related with one variable).
2. Pareto chart: A Pareto chart is a type of chart that contains both bars and a line
graph, where individual values are represented in descending order by bars, and
the cumulative total is represented by the line.
3. Cause and effect diagram (Fish bone diagram): It helps to identify the
possible causes of a specific problem or quality characteristic.
4. Defect concentration diagram.
5. Control chart: The control chart is a graph used to study how a process
changes over time. Data are plotted in time order. A control chart always has a
central line for the average, an upper line for the upper control limit and a lower
line for the lower control limit.
6. Scatter diagram: The scatter diagram graphs pairs of numerical data, with one
variable on each axis, to look for a relationship between them. If the variables
are correlated, the points will fall along a line or curve.
7. Check sheet: The check sheet is a form or document used to collect data in real
time at the location where the data is generated.
Advantages
1. Improve in quality and safety of the drugs.
2. Improvement of customer satisfaction.
3. Improvement of reputation of industry.
4. Total involvement of employee with higher moral and responsibilities.
5. Lower economic burden